Video Screening for Visual Impairment of Infants

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT04237350
Collaborator
(none)
3,740
1
25.5
146.7

Study Details

Study Description

Brief Summary

An individual senses the world and reflects feedbacks via independent behaviors. Such precise collaboration of the sensory and behavioral systems is fundamental to survival and evolution. When a sensory modality is altered, the behavioral system has the potential to fit in a substitute modality. However, the specific dynamics of human behaviors in response to sensory loss remain largely unknown due to the paucities of representative situations and large-scale samples.

Here, the investigators focused on thousands of human infants who suffered varying degrees of visual stimuli deficiency in early stages, while their behavioral systems remained sensitive and thus retained high behavioral plasticity. Having access to this unique population provides an unprecedented opportunity to investigate the effect of diverse visual conditions on the behavioral system and develop a domestic apparatus for screening visual impariment of infants.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Video recording for behaviors

Study Design

Study Type:
Observational
Actual Enrollment :
3740 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Video Screening for Visual Impairment of Infants
Actual Study Start Date :
Jan 14, 2020
Actual Primary Completion Date :
Jan 30, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
severe visual impairment group

The "severe visual impairment" group is defined as the BCVA of at least one eye outside the 99% referenced range or worse than light perception with structural abnormalities or other examination results.

Behavioral: Video recording for behaviors
A domenstic apparatus, scenario, and procedure is applied to record all the behavioral phenotypes. For each standardized procedure, the guardian sits in the chair, holding the infant facing the mobile phone screen. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for about 3 minutes to ensure that behavioral phenotypes could be completely recorded.

likely healthy group

For the "likely healthy" group, the visual acuity of both eyes is in the 95% referenced range with no structural abnormalities. The referenced range could be found in the following publication: Mayer, DL., et al. Monocular acuity norms for the Teller Acuity Cards between ages one month and four years. Investigative Ophthalmology & Visual Science. 36(3):671 (1995)

Behavioral: Video recording for behaviors
A domenstic apparatus, scenario, and procedure is applied to record all the behavioral phenotypes. For each standardized procedure, the guardian sits in the chair, holding the infant facing the mobile phone screen. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for about 3 minutes to ensure that behavioral phenotypes could be completely recorded.

mild visual impairment group

The "mild visual impairment" group is defined as the BCVA in the 99% referenced range in both eyes with abnormalities of structure or other examination results.

Behavioral: Video recording for behaviors
A domenstic apparatus, scenario, and procedure is applied to record all the behavioral phenotypes. For each standardized procedure, the guardian sits in the chair, holding the infant facing the mobile phone screen. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for about 3 minutes to ensure that behavioral phenotypes could be completely recorded.

Outcome Measures

Primary Outcome Measures

  1. The AUC of model based on analyzing the behavioral dynamics [baseline]

    Normal or abnormal behavioral dynamics of infants are recorded by mobile phones. Five experienced ophthalmologists identify the occurence of abnormal behaviors independently, and 2 professors with over 10 years of experience in pediatric ophthalmology department are consulted in cases of disagreement. The AUC of model based on analyzing the behavioral dynamics will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 4 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Younger than 4 years of age
Exclusion Criteria:
  • Any brain and mental illnesses, or other known illnesses that may affect the behavioral patterns

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Study Chair: Yizhi Liu, Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haotian Lin, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04237350
Other Study ID Numbers:
  • CCPMOH2019-China-7
First Posted:
Jan 23, 2020
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2022